The purpose of this study is to determine the safety and effectiveness of AGS-004, an immune therapy, for HIV-infected individuals. Safety and effectiveness will be tested while the individuals are both taking antiretroviral therapy (ART) medication and interrupting ART medication.

The purpose of this study is to determine the safety and effectiveness of AGS-004, an immune therapy, for HIV-infected individuals. Safety and effectiveness will be tested while the individuals are both taking antiretroviral therapy (ART) medication and interrupting ART medication

Eligibility

Ages Eligible for Study:

18 Years to 60 Years (Adult)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Males and females ≥ 18 to 60 years of age.

HIV infection.

Stable ART regimen for ≥ 3 months prior to Screening.

HIV VL level ≤ 400 copies/mL for ≥ 2 months prior to Screening.

HIV VL level ≤ 50 copies/mL at Screening.

CD4+ T cell count ≥ 450 cells/mm3 at Screening.

Pre-ART nadir CD4+ T cell counts ≥ 200 cells/mm³.

Availability of an adequate sample of frozen plasma most recently collected (no more than 90 days and preferably within 30 days) before starting ART.

Laboratory values within pre-defined limits at Screening and Eligibility.

Negative serum pregnancy test at Screening and Eligibility for females with reproductive potential, and agreement of all subjects to use a reliable form of contraception during the study and for 12 weeks after the last dose of study drug.

Able and willing to give adequate written informed consent, to communicate effectively with study personnel, and willing to be compliant with protocol requirements.

History of moderate or severe renal impairment (i.e., persistent history of creatinine clearance < 50 mL/min) or any other renal disorder deemed clinically significant by the investigator.

Prior history of an acquired immunodeficiency syndrome (AIDS) defining condition.

History or other evidence of severe illness, malignancy, immunodeficiency other than HIV, or any other condition that would make the subject unsuitable for the study in the opinion of the investigator.

Known allergy or sensitivity to the components of the investigational immunotherapy.

Active drug or alcohol use or dependence that would interfere with adherence to study requirements in the opinion of the investigator.

Use of systemic corticosteroids and use of topical steroids over a total area exceeding 15 cm² within 30 days prior to Screening.

Any investigational antiretroviral agents or use of a CCR5 inhibitor at Screening.

Active autoimmune disease or condition.

Participation in another investigational clinical study within the previous 30 days or use of investigational agents.

Body weight less than 30 kg.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01069809